Summary of Cancellation for Evenity
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Contact:
Medicinal ingredient(s):
Romosozumab
Therapeutic area:
Drugs for treatment of bone diseases
Type of submission:
Supplement to a New Drug Submission
Control number:
262756
Decision issued:
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation:
2023-03-21
What was the purpose of this submission?
This Supplement to a New Drug Submission (SNDS) sought an indication for Evenity (romosozumab) for the treatment of men with osteoporosis.
What did the company submit to support its submission?
The Sponsor submitted clinical efficacy, safety, and pharmacology data in support of the submission. This included a Phase 3 study in 245 men with osteoporosis. The primary and key secondary endpoints were change from baseline in bone mineral density at the lumbar spine, total hip, and femoral neck. The study did not assess fracture risk.
What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
Health Canada’s review of the submission was ongoing at the time of cancellation. The assessment had identified issues with the clinical evidence provided to support the proposed indication in male osteoporosis for romosozumab. These issues were not resolved at the time of cancellation.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact for patients using SAP or in clinical trials.
Romosozumab remains available for use in postmenopausal women with osteoporosis in Canada.
Manufacturer:
Amgen Canada Inc.
Drug Identification Numbers issued:
N/A
Date filed:
2022-03-24
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| EVENITY | 02489597 | AMGEN CANADA INC | ROMOSOZUMAB 105 MG / 1.17 ML |